The first participants in an international clinical study were aimed at preventing Alzheimer’s disease in young adults with a high risk of the disease. The test, led by the Washington University School of Medicine in St. Louis, is intended to determine whether stopping early molecular changes that lead to the symptomatic Alzheimer’s disease can prevent the disease ever holding. The study registers people, as young as 18 who have little or no detectable Alzheimer-related molecular changes in their brains, up to 25 years before the expected start of the symptoms of dementia.
Although the test is limited to members of families with genetic mutations that are anything but guarantee that they will develop Alzheimer’s at a young age, usually in their 30s, 40s or 50s, the researchers expect the results of the study to the prevention and treatment efforts for all Forms will inform for all forms of Alzheimer’s disease.
The primary prevention study, the new study is investigating whether Remnetug – a research firm that is being developed by Eli Lilly and Company – can remove plaques from an important Alzheimer’s protein named Amyloid beta from the brain or block them to gather in the first place. Both genetic and non -genetic forms of Alzheimer’s disease start with amyloid that slowly collects in the brain, two decades before memory and thinking problems occur. By cleaning up low levels of amyloid beta plaques or preventing them from accumulating during the early, asymptomatic phase of the disease, or both, the researchers hope to interrupt the disease process in the earliest stage and save people to ever symptoms to ever symptoms to develop.
In recent years we have seen enormous progress in the treatment of Alzheimer’s disease. Two amyloid-oriented drugs turned out to be slowing down the symptoms of the disease and are now approved by the Food and Drug Administration (FDA) as treatments for people with mild cognitive impairment or mild dementia due to Alzheimer’s disease. This offers strong support for our hypothesis that intervene when amyloid beta plaques are in the very first stage, long before the symptoms occur, symptoms can prevent emerging in the first place. “
Eric Mcdade, Do, Professor in Neurology and the most important researcher of the test
The test is part of the dominant hereditary Alzheimer Network (Dian) Trials Unit (Dian-Tu), a clinical research platform that is designed to find medicines to prevent or treat Alzheimer’s disease. It is closely linked to Dian, a National Institutes of Health (NIH) funded international research network under the leadership of WASHU Medicine in which research institutes are involved in North America, Australia, Europe, Asia and South America. Dian follows families with mutations in one of the three genes that Alzheimer’s cause at a young age. A child born in such a family has a 50% chance of inheriting such a mutation, and those who do this usually develop signs of dementia near the same age that his or her parent did. All participants in the primary prevention test come from such families.
“My grandfather died of the Alzheimer’s, and his mother and all except one,” said Hannah Richardson, 24, a participant in the primary prevention test. “My mother and my uncle participated in Dian tests since I was about 10 years old. My mother was always very open about her diagnosis and how it encouraged her advocacy for Alzheimer’s research, and I always knew that I wanted to follow Her footsteps.
The test was first announced in 2021. At that time, the researchers were planning to use a different research medicine – Gantenerumab, by Roche/Genentech. However, Roche/Genentech stopped the development of Gantenerumab after data from other Alzheimer’s tests were not supportive.
Remodetuguk was chosen as a replacement, because in the early phase investigations in symptomatic patients with more common forms of Alzheimer’s, the amyloid plaques robust in a comparable extent such as Donanemab removes an Alzheimer’s therapy, approved by the FDA, also produced by Lilly. It is important that inhibition can be given through injection just below the skin, a faster and less invasive route of administration than IV infusion, as the approved treatments are currently being delivered. In addition, the participants receive a dehter network or placebo every 3 months, a less frequent dosing schedule than the biweekly or monthly dosing schedules needed for the two Alzheimer’s medicines approved by the FDA. The results will help scientists determine the optimum dosing schedule for prevention.
Each participant is treated for two years. McDade expects to report the results of the process within the next four to five years, depending on how long it takes to achieve the registration goals.
“We are delighted to work with the Dian-TU team to evaluate whether remeding network can help slow or prevent the accumulation of amyloid plaque, a determining event in the early cascade of Alzheimer’s disease,” said Mark Mintun, MD, Groupvice-President- Neuroscience R&D at Lilly.
The primary prevention study will register from around 240 participants with families who carry mutations in one of the three most important genes that Alzheimer’s cause with early start. Both those who have inherited the mutation and did not inherit are eligible, whereby not -carriers who serve as a comparison group for their family members. Participants must be 11 to 25 years younger than the expected age of the beginning of symptoms based on their family history, and have no signs of cognitive disorders and no or very little amyloid deposits in their brains. At the end of the experimental period, participants who bear a mutation are eligible to receive the medicine for another four years as part of an open label extension of the study.
McDade and colleagues are primarily looking to see if Remnetug prevents amyloid plaques from building up in the brain. They will also measure the effects of the drug on molecular signs of Alzheimer’s disease in the blood and brain fluid. Because the participants are so young, the researchers do not expect any changes in the cognitive function during the test period. Washu Medicine will continue to follow the participants in the long term than the clinical study to assess the potential effects on cognition.
More than $ 130 million has been reserved for the process, including subsidies of a total of $ 98.3 million from the NIH’s National Institute on Aging (NIA) and $ 14 million from the Alzheimer’s Association and the GHR Foundation. The NIA is an important proponent of Dian and his clinical proof unit since the network was founded in 2008.
“The Alzheimer’s Association is proud to be a long -term part of this strong collaboration between academic researchers, government, industry, philanthropy and the Dian families,” said Maria C. Carrillo, PhD, Alzheimer’s Association Chief Science Officer and Medical Affairs Lead . “This innovative study in this special Alzheimer’s patient population has the potential to significantly influence how we prevent Alzheimer’s disease, which saves individuals and families from the fear of this fatal disease.”
In addition, Washu has promised to raise an extra $ 6.5 million extra, and the old Washu -wanderer and the researchers of Alzheimer’s, Joanne Knight from St. Louis and the family, have committed up to $ 11.5 million to support the process.
“Alzheimer’s disease has hit our family in several generations for decades,” said Joanne Knight. “We are so happy that we have the opportunity to support this research aimed at preventing the devastating effects of the disease.”
The primary prevention of the Knight Alzheimer’s challenge has already been given more than 150 donors. The test is carried out in close collaboration with Lilly, which also offers considerable financing.
“This is a groundbreaking approach,” said Fred Miller, Chief Operating Officer of GHR Foundation. “For the first time we are working on preventing the building of Alzheimer’s pathology before it starts. The research will provide insight into how we prevent Alzheimer’s disease for these families, as well as the nearly 13 million Americans who are expected to disease the disease of Alzheimer’s have 2050 and countless others around the world.
Together with the Dian-Tu Primary Prevention Trial, Washu Medicine also runs the International Dian-Tu Tau Nexgen Trial, which is aimed at identifying medicines to prevent or delay Alzheimer’s. Just like the primary prevention study, the Tau Nexgen study concerns members of families who wear dominant Alzheimer’s mutations, but those in Tau Nexgen are located on or near the age of the beginning of the symptoms and have already collected significant brain changes. Tau Nexgen is evaluating or a combination of the pharmacists approved by the FDA, which focuses on amyloid, and another medicine that focuses on an Alzheimer-related protein called Tau, stop or delay the progression of the disease.